COVID-19 remains a public health challenge, particularly among older adults and high-risk populations1 Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability profile to global markets, providing an important option for healthcare providers and patients Aug. 28, 2026 -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major ma

Spyre Therapeutics' stock was down about 14% Wednesday after a topline readout for one of its experimental TL1A antibodies underwhelmed in a Phase II rheumatoid arthritis (RA) study. While SPY072 showed activity, it failed to meet the company's internal efficacy bar for moving it forward as a stand-alone therapy. The candidate is being evaluated in the SKYWAY-RD basket trial across several rheumatic diseases, with separate sub-studies in RA, psoriatic arthritis (PsA) and axial spondyloarthritis

Biohaven on Wednesday said it’s selling the rights to its most advanced experimental medicine to South Korea’s SK Biopharmaceuticals in a deal that may be worth as much as $795 million plus future royalties. The transaction includes access to Biohaven’s Kv7 ion channel technology and the lead asset to emerge from that platform, a treatment for focal epilepsy called opakalim. The drug is currently in late-stage testing, and topline results from a trial called Rise3 are due before the end of the

The RAS revolution is officially here, thanks to the FDA's approval of Rasonque (daraxonrasib) for adults with metastatic pancreatic ductal adenocarcinoma (PDAC) on Wednesday. Revolution Medicines' RAS inhibitor was greenlit less than five months after it first revealed "practice-changing" data suggesting the candidate could help patients live twice as long as standard chemotherapy (see – Spotlight On: Daraxonrasib set to revolutionise pancreatic cancer treatment landscape). "This drug showed u

Shanghai Minwei Biotechnology Co., Ltd. has registered a Phase I first-in-human clinical trial of MWN110, a monoclonal antibody targeting activin receptors ActRIIA and ActRIIB, in healthy volunteers and people with overweight or obesity. The study marks the first human trial of the asset, which Minwei, a subsidiary of Lepu Medical Technology (SHE: 300003), said was developed in-house and is covered by intellectual property rights held by the company. The study (NCT07779980) is a randomized, dou

Gossamer Bio has announced a private placement agreement valued at up to $250m, including $150m of committed capital intended to support the development and potential US Food and Drug Administration (FDA) approval of seralutinib. Seralutinib is intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The private investment comprises an initial closing, a subsequent closing contingent upon FDA acceptance o

Charles River Laboratories (CRL) and Taiwan-based Medigen Vaccine Biologics are teaming up to prep Medigen’s multivalent enterovirus vaccine for global expansion. The collaboration is designed to characterize and validate the virus seed bank for Medigen’s vaccine and will leverage CRL’s analytical platforms, according to a Thursday release . CRL’s Next-Generation Sequencing will support the chemistry, manufacturing and controls steps to advance the vaccine program, including Medigen’s Envacgen

The FDA on Friday approved Takeda and Protagonist Therapeutics' Mimrylo (rusfertide) to treat adults with polycythemia vera (PV), making it the first hepcidin mimetic cleared to treat the rare blood disorder. Current treatment options for PV, like hydroxyurea and interferons, as well as Incyte's Jakafi (ruxolitinib), are "ineffective in a majority of patients," Protagonist President and CEO Dinesh Patel previously told FirstWord. Patients have also historically relied on phlebotomies to keep th

In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk. On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of ad

TSY-110 is positioned to become the first biosimilar alternative to Roche's Kadcyla® (ado-trastuzumab emtansine) in major regulated markets. Aug. 28, 2026 -- Formosa Pharmaceuticals, Inc. (TWSE: 6838), today announced the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110. TSY-110 is a biosimilar candidate referencing Roche's antibody-drug conjugate (ADC) Kadcyla® (ado-trastuzumab emtansine), indicated for HER2-pos